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Chantix Smoking Cessation Drug to Undergo Safety Review Following Reports of Suicide, Erratic Behavior

Nov 20, 2007 | Parker Waichman LLP

Chantix, a smoking cessation drug marketed by Pfizer, is undergoing a Food & Drug Administration (FDA) safety review following reports that linked the drug to psychological problems, including suicidal thoughts and erratic behavior.  Chantix was recently implicated in the violent death of prominent Dallas musician Carter Albrecht who had been taking the medication on the night he was killed.

Chantix
, approved in 2006, works by blocking nicotine receptors to the brain.  Chantix is the first such nicotine receptor partial agonist approved by the FDA.  It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.  The Chantix label warns of various side effects, including nausea, changes in dreaming, constipation, gas and vomiting.    But those warnings are more prominent and easier to find than the fine print on the package insert that warns of the possibility of psychotic and suicidal behavior.

Such Chantix side effects may have played a part in the death of musician Carter Albrecht.  Albrecht, best known as a member of Edie Brickell and the New Bohemians, started taking Chantix in late August 2007.   He was well liked in the community, and had no prior history of violence.  Immediately, Albrecht began to complain of vivid, hallucinatory dreams -- a common Chantix side effect. One night about a week after he started taking Chantix, Albrecht had a violent encounter with his girlfriend.   The episode occurred after Albrecht had consumed a couple of alcoholic drinks.  Albrecht’s girlfriend reported that he was confused, and did not recognize her.  Before the night was over, Albrecht had been shot dead by a terrified neighbor on whose property he had trespassed.

According to the FDA, Pfizer recently submitted several postmarketing cases to the agency describing suicidal thoughts and occasional suicidal behavior possibly linked to Chantix use.  The FDA said it is currently reviewing these cases, along with a number of recent highly publicized incidents in the media (presumably the Albrecht death).   The FDA said that its preliminary assessment revealed that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.  The role of Chantix in these cases is not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness.  However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.

The FDA is also evaluating reports from Pfizer of drowsiness in patients taking Chantix.  The reports described patients who experienced drowsiness that affected their ability to drive or operate machinery.

The FDA is recommending that healthcare professionals monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes. Patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.


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